MAUDE Adverse Event Report: ARTHREX, INC. UNIVERS REVERS STEM, SIZE 7, CAP COATED; PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED

Model Number UNIVERS REVERS STEM, SIZE 7, CAP COATED

Device Problems Improper or Incorrect Procedure or Method (2017); Appropriate Term/Code Not Available (3191)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 11/14/2017

Event Type  Injury  

Manufacturer Narrative

The contribution of the device to the reported event could not be determined as the device was not returned for evaluation.The root cause of the event could not be determined from the information available and without device evaluation.

Event Description

It was reported by the patient's legal representative that on or about (b)(6) 2017 the patient underwent a shoulder arthroplasty surgery.It was reported that the operation required implantation of a specific millimeter-sized polyethylene liner and the wrong sized liner was provided to the surgeon.It was further reported that the hardware implanted did not match the trial components the surgeon had selected for the patient and improper prosthetic components were implanted causing the need for subsequent surgical treatment.The following devices were implanted during the initial (b)(6) 2017 procedure: ar-9503s-03, univers revershumeral insert small/36/+3, lot 170052310, ar-9502f-36cpc, univers rever suture cup, 39(neutral) (lot 160117904 or lot 170039706 - specific lot unknown), ar-9501-07cpc, univers revers stem, size 7, lot 170035214, ar-9504m-04, univers revers glenosphere 39 +4 lat, lot 160123713, ar-9165-20nl, central screw, non-locking, uni rev, 6.5 x 20mm, lot 10070240, ar-9145-30, uni glenoid-peripheral locking screw, lot 17009612, ar-9145-24, uni glenoid-peripheral locking screw, lot 160115411, ar-9120-02, universal glenoid baseplate medium, lot 2501470208.Additional information obtained 02/07/2020: the patient's original procedure took place (b)(6) 2017.Thereafter, when the sales rep was entering the invoice information he noticed that the wrong sized cup and liner were used.He notified the surgeon immediately and the patient was revised with the right sized cup and liner and the stem was changed.It was reported that the revision took place 3 days after the initial surgery.During the revision procedure the original humeral insert, suture cup and stem were explanted and the following devices were implanted: ar-9503m-03, univers revers humeral insert medium/39/+3, lot 160076509 , ar-9502f-39cpc, univers revers suture cup 39 neutral, lot 160059303, ar-9501-08cpc, univers revers stem size 8, lot 170022614.

• Brand Name: UNIVERS REVERS STEM, SIZE 7, CAP COATED
• Type of Device: PROSTHESIS, SHOULDER, SEMI-CONSTRAINED, METAL/POLYMER CEMENTED
• Manufacturer (Section D): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer (Section G): ARTHREX, INC.; 1370 creekside boulevard; naples FL 34108 1945
• Manufacturer Contact: vik bajnath ; 8009337001
• MDR Report Key: 9751212
• MDR Text Key: 190888598
• Report Number: 1220246-2020-01717
• Device Sequence Number: 1
• Product Code: KWS
• UDI-Device Identifier: 00888867061019
• UDI-Public: 00888867061019
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K130129
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: other
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 02/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 05/31/2022
• Device Model Number: UNIVERS REVERS STEM, SIZE 7, CAP COATED
• Device Catalogue Number: AR-9501-07CPC
• Device Lot Number: 170035214
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 02/07/2020
• Initial Date FDA Received: 02/25/2020
• Date Device Manufactured: 07/12/2017
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other